Director, Global Clinical Development

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Design and manage clinical research initiatives and protocols for OPDC products in accordance with GCP standards.

• Assess and support the clinical development of products related to Rare Diseases, Inherited Metabolic Diseases, and Specialty Medicine across various stages of development.

• Collaborate with patients, their representatives, and clinical, regulatory, and scientific leaders to enhance trial objectives, designs, and protocols.

• Act as a clinical/medical scientific advisor to health economics, medical affairs, marketing, regulatory, statistical, and research project teams, as well as external regulatory agencies.

• Develop program strategies like GDCP and supervise trials that evaluate safety, efficacy, medical utility, and product value.

• Analyze and convey Phase I–IV investigation findings for new drug preparations.

• Serve as the signatory for NDA submissions and clinical study and safety documentation.

• Support product life-cycle management and identify strategic innovations.

• Ensure strategic oversight of vendor and CRO relationships and provide clinical input to governance committees.

• Lead and assist in regulatory filing efforts and documentation.

• Provide strategic guidance and editing for clear, concise, and persuasive written and verbal communications.

⛳️ Requirements

• Essential clinician qualification: M.D. or D.O., ideally a geneticist, metabolic physician, rare disease specialist, or immunology expert.

• Highly qualified applicants with other clinical/scientific doctorates may be considered if supported by a team or consulting clinician.

• Typically, 3–6 years of experience in the pharmaceutical industry, clinical practice, or academic translational clinical research is required for the Director level, depending on the type of experience.

• A minimum of 5 years of experience in clinical research or drug development within an academic or industry context is necessary.

• Experience across clinical activities spanning Phases I through IV.

• Extensive knowledge of clinical medicine and science management.

• Proven ability to establish critical objectives and achieve business outcomes within time, budget, and quality constraints.

• Strong communication skills for effective participation in meetings and in written and oral presentations.

• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

• Demonstrated experience in leading, managing, and motivating internal staff as well as external investigators or consultants.

• Advanced understanding of drug development principles and the implementation, management, and reporting of clinical trials.

• Flexibility to work across various therapeutic areas and stages of clinical development.

• Working knowledge of immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.

• Comprehensive understanding of global regulatory requirements.

🏝️ Benefits

• Incentive opportunity

• Comprehensive medical coverage

• Dental coverage

• Vision coverage

• Prescription drug coverage

• Company-provided basic life insurance

• Accidental death & dismemberment insurance

• Short-term disability insurance

• Long-term disability insurance

• Tuition reimbursement

• Student loan assistance

• Generous 401(k) match

• Flexible time off

• Paid holidays

• Paid leave programs

• Other company-provided benefits